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Purpose

Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • regular cannabis use
  • good health other than cannabis use
  • willingness to attempt abstinence
  • effective form of birth control in female subjects
  • available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria

  • medical screening outcomes outside normal ranges or deemed clinically insignificant
  • medical history that would contraindicate pregabalin administration

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pregabalin 1
Dose 1
  • Drug: Pregabalin
    pregabalin 2x daily for duration of study
Placebo Comparator
Placebo 1
Placebo 1
  • Drug: Placebo
    placebo 2x daily for duration of study
Experimental
Pregabalin 2
Dose 2
  • Drug: Pregabalin
    pregabalin 2x daily for duration of study
Placebo Comparator
Placebo 2
Placebo 2
  • Drug: Placebo
    placebo 2x daily for duration of study

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky 40536-0086
Contact:
Frances Wagner, RN
859-257-5388
fpwagn2@uky.edu

More Details

NCT ID
NCT01511640
Status
Recruiting
Sponsor
Joshua A. Lile, Ph.D.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.